Class II
Terminated
Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8.
This recall has been terminated (originally issued October 9, 2013).
- Company
- Marlex Pharmaceuticals, Inc.
- Recall Initiated
- August 8, 2013
- Posted
- October 9, 2013
- Recall Number
- D-1064-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 28,387 bottles
- Firm Location
- New Castle, DE, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.
Distribution
Nationwide.
Lot / Code Info
Lot #: 3213, Exp 12/13
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